Biological indicator and method for producing the same

Abstract

A biological indicator including a carrier and an indicator material, said indicator material adhering on the surface of the carrier, and having a contact portion being contact with the surface of the carrier and a non-contact portion being not in contact with the surface of the carrier, and wherein the carrier includes an adhering area having a adhering portion to which the indicator material adheres and a non-adhering area having an non-adhering portion to which the indicator material does not adhere.

1 . A biological indicator including:
 a carrier, and   an indicator material; said indicator material adhering on the surface of the carrier, and having a contact portion being contact with the surface of the carrier and a non-contact portion being not in contact with the surface of the carrier, and   wherein the carrier includes an adhering area having a adhering portion to which the indicator material adheres and a non-adhering area having an non-adhering portion to which the indicator material does not adhere.   
   
   
       2 . The biological indicator according to  claim 1 ,
 wherein all of the indicator materials exist within a range of 2 μm from the carrier surface.   
   
   
       3 . The biological indicator according to  claim 1 ,
 wherein a plurality of the adhering areas exist as a domain.   
   
   
       4 . The biological indicator according to  claim 3 ,
 wherein the shape of the plurality of adhering areas existing as a domain is approximately circular form, and   density of the indicator materials in each of the plurality of adhering areas becomes higher in an outer circumference portion and in the vicinity thereof of the adhering area.   
   
   
       5 . The biological indicator according to  claim 1 ,
 wherein the indicator material is a spore-forming bacterium.   
   
   
       6 . The biological indicator according to  claim 5 ,
 wherein at least a part of 90% or more of the spore-forming bacteria can be visually confirmed when seen from a direction perpendicular to the surface of the carrier.   
   
   
       7 . The biological indicator according to  claim 6 ,
 wherein adjacent spore-forming bacteria adhere on the carrier surface without overlapping to each other.   
   
   
       8 . The biological indicator according to  claim 6 ,
 wherein a plurality of the adhering areas exist as a domain, and at the same time 1 to 100 spore-forming bacteria are included in one adhering area.   
   
   
       9 . The biological indicator according to  claim 5 ,
 wherein at least protein or polymer exists on the carrier surface.   
   
   
       10 . The biological indicator according to  claim 9 ,
 wherein the protein is albumin.   
   
   
       11 . The biological indicator according to  claim 9 ,
 wherein the polymer is carboxyl methyl cellulose or polyethylene glycol.   
   
   
       12 . The biological indicator according to  claim 5 ,
 wherein the number of spore-forming bacteria adhering on the carrier surface is between 5×10 5  and 2×10 6 .   
   
   
       13 . The biological indicator according to  claim 1 ,
 wherein the indicator material is endotoxin.   
   
   
       14 . The biological indicator according to  claim 13 ,
 wherein all of the indicator materials exist within a range of 100 nm from the carrier surface.   
   
   
       15 . The biological indicator according to  claim 1 ,
 wherein the carrier is an impermeable substrate through which fluid cannot permeate or a permeable substrate through which fluid can permeate.   
   
   
       16 . The biological indicator according to  claim 1 ,
 wherein the material constituting the carrier is one member selected from the group consisting of polystyrene, polypropylene, polyethylene terephthalate, or stainless.   
   
   
       17 . The biological indicator according to  claim 1  which is to be used to evaluate effectiveness of a disinfection, sterilization, bacteria elimination, or toxin degradation apparatus using radiation for disinfection, sterilization, bacteria elimination, or toxin degradation which is aspect irradiated to a target. 
   
   
       18 . A method for manufacturing a biological indicator according to  claim 1  comprising:
 a step of discharging solution or dispersion fluid including an indicator material from a discharging unit as minute droplets by ink jet method so that the droplets are caused to land on a carrier surface and thereafter drying the droplets which have landed on the carrier surface.   
   
   
       19 . The manufacturing method of a biological indicator according to  claim 18 ,
 wherein the quantity of a drop of the minute droplet is between 1 and 500 pl.   
   
   
       20 . The manufacturing method of a biological indicator according to  claims 18 ,
 wherein the indicator material is a spore-forming bacterium, and the dispersion fluid includes the spore-forming bacterium dispersed with the concentration of 1×10 2  to 1×10 7 /μl.   
   
   
       21 . The manufacturing method of a biological indicator according to  claim 20 ,
 wherein the dispersion fluid is alcohol dispersion fluid in which the spore-forming bacteria are dispersed in an alcohol solvent.   
   
   
       22 . The manufacturing method of a biological indicator according to  claim 21 ,
 wherein the alcohol solvent is alcohol aqueous solution having alcohol concentration of between 20 and 80% by mass.   
   
   
       23 . The manufacturing method of a biological indicator according to  claim 20 ,
 wherein the dispersion fluid is the spore-forming bacteria dispersed into the concentration of 1×10 3  to 1×10 7 /μl, and   the quantity of a drop of the minute droplet is between 50 and 200 pl.   
   
   
       24 . The manufacturing method of a biological indicator according to  claim 18 ,
 wherein the discharging unit has an inlet having a filter through which the solution or the dispersion fluid is instilled.